Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated With Improved Effectiveness and Disease Outcomes

Koliani-Pace, Jenna L.; Singh, Siddharth; Luo, Michelle; Hirten, Robert; Aniwan, Satimai; Kochhar, Gursimran; Chang, Shannon; Lukin, Dana J.; Gao, Youran; Bohm, Matthew; Swaminath, Arun; Gupta, Nitin; Shmidt, Eugenia; Meserve, Joseph; Winters, Adam C.; Chablaney, Shreya; Faleck, David; Jiao, Yang; Huang, Zhongwen; Boland, Brigid S.; Shashi, Preeti; Weiss, Aaron; Hudesman, David; Varma, Sashidhar; Fischer, Monika; Sultan, Keith; Shen, Bo; Kane, Sunanda V.; Loftus, Edward V.; Sands, Bruce E.; Colombel, Jean Fréd́eric; Sandborn, William J.; Lasch, Karen; Siegel, Corey A.; Dulai, Parambir S.

doi:10.1093/ibd/izz071

Cited by 13 publications

(12 citation statements)

References 13 publications

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“…The remission rates reported in adult studies are higher than the rates observed in the children in our cohort (17,24), which may be explained by inclusion of anti-TNF refractory PIBD patients only, whereas this was not the case in the adult studies. This is supported by studies showing significantly better outcomes in anti-TNF-naïve IBD patients (25)(26)(27) explanation for loss of response to anti-TNF, our data do not suggest that nonresponse or loss of response to VDZ can be explained by the formation of antibodies to VDZ (28). This is consistent with studies in adults that indicate immunogenicity to occur in <5% of cases (17,29).…”

Section: Discussionsupporting

confidence: 91%

Vedolizumab Trough Levels in Children With Anti‐Tumor Necrosis Factor Refractory Inflammatory Bowel Disease

Aardoom

Jongsma

Vries

et al. 2020

J. pediatr. gastroenterol. nutr.

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Objectives: Inflammatory bowel disease (IBD) can be successfully treated with vedolizumab. Studies in adult IBD patients have shown that differences in response to vedolizumab may be related to variability in vedolizumab trough levels, but in children with pediatric-onset IBD data regarding vedolizumab trough levels are not available. Thus far, the role of trough levels in pediatriconset IBD treatment remains unclear. We aimed to investigate predictors of vedolizumab trough levels in pediatric-onset IBD patients. Methods: Data from anti-tumor necrosis factor refractory pediatric-onset IBD patients who received vedolizumab were collected retrospectively. Vedolizumab trough levels were measured in serum samples collected before each infusion. A linear mixed model was conducted to analyze factors that influence trough levels. Results: Twenty-six pediatric-onset IBD patients (14 ulcerative colitis [UC]), 9 Crohn Disease [CD], 3 IBD-unclassified [IBD-U]) received 258 vedolizumab infusions. Mean vedolizumab trough level at week 6 was 29.9 mg/mL (SD 17.8), and 11.5 mg/mL (SD 4.9) during maintenance therapy. CD patients had significantly lower trough levels than IBD-U patients (b 15.2; 95% confidence interval [CI] À1.1 to 29.2; P ¼ 0.036). Higher fecal calprotectin (b À0.009; 95% CI À0.02 to À0.003; P ¼ 0.007) and C-reactive protein levels (b À0.4; 95% CI À0.72 to À0.04; P ¼ 0.027) were associated with lower trough levels, whereas shortening of time between infusions led to higher trough levels (b À0.77; 95% CI À0.9 to 0.64; P < 0.001). Conclusions: In this group of pediatric-onset IBD patients, trough levels were significantly lower in CD patients compared with UC/IBD-U patients. Higher levels of inflammatory markers were associated with lower vedolizumab trough levels.

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Section: Discussionsupporting

confidence: 91%

Vedolizumab Trough Levels in Children With Anti‐Tumor Necrosis Factor Refractory Inflammatory Bowel Disease

Aardoom

Jongsma

Vries

et al. 2020

J. pediatr. gastroenterol. nutr.

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“…Prior work from our group has observed that inflammatory bowel disease patients treated with vedolizumab early after its approval and availability in the market were more refractory and had lower persistence rates compared to more recent utilisation. 37 Therefore, it's possible that these differences were related to utilisation patterns in which vedolizumab-treated patients earlier in the period were simply more refractory requiring early discontinuation and those treated later in the observation period had less time to be exposed to the drug.…”

Section: Discussionmentioning

confidence: 99%

Comparative safety and effectiveness of vedolizumab to tumour necrosis factor antagonist therapy for Crohn's disease

Bohm

Zhang

et al. 2020

Aliment Pharmacol Ther

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Summary Background Direct comparisons are lacking between vedolizumab and tumour necrosis factor (TNF)‐antagonist therapy in Crohn's disease (CD). Aim To compare safety and effectiveness of vedolizumab and TNF‐antagonist therapy in adult CD patients. Methods Retrospective observational cohort (May 2014–December 2017) propensity score‐weighted comparison of vedolizumab vs TNF‐antagonist therapy (infliximab, adalimumab, certolizumab) in CD. Propensity scores were weighted for age, prior treatments, disease complications, extent and severity, steroid dependence, and concomitant immunosuppressive drug use. The primary outcome was comparative risk for infections or non‐infectious serious adverse events (requiring antibiotics, antivirals, antifungals, hospitalisation, or treatment discontinuation, or resulting in death). Secondary comparative effectiveness outcomes were clinical remission (resolution of CD‐related symptoms), steroid‐free clinical remission and endoscopic remission (absence of ulcers/erosions). Results We included 1266 patients (n = 659 vedolizumab). Rates of non‐infectious serious adverse events (odds ratio [OR] 0.072, 95% confidence interval [CI] 0.012‐0.242), but not serious infections (OR 1.183, 95% CI 0.786‐1.795), were significantly lower with vedolizumab vs TNF‐antagonist therapy. Safety comparisons for non‐infectious serious adverse events remained significant after adjusting for differences in duration of exposure. No significant difference was observed between vedolizumab and TNF‐antagonist therapy for clinical remission (hazard ratio [HR] 0.932, 95% CI 0.707‐1.228), steroid‐free clinical remission (HR 1.250, 95% CI 0.677‐2.310) or endoscopic remission (HR 0.827, 95% CI 0.595‐1.151). TNF‐antagonist therapy was associated with higher treatment persistence compared with vedolizumab. Conclusions There was a lower risk of non‐infectious serious adverse events, but not serious infections, with vedolizumab vs TNF‐antagonist therapy, with no significant difference for achieving disease remission.

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“…The 12-month analysis (b) included data reported from 52 weeks to 13.5 months. Cumulative rates from ERA 2 of the VICTORY trial reported by Koliani-Pace [49] were higher than those observed for other studies included in this meta-analysis. Endpoint definitions: absence of ulcers/erosions and/or Simple Endoscopic Score for Crohn's Disease cut − points < 4 (Table 2).…”

Section: Discussioncontrasting

confidence: 75%

“…In the VER-SIFY phase 3b clinical trial, rates of endoscopic remission (SES-CD score of ≤ 4) and endoscopic response (≥50% reduction in baseline SES-CD score) at 52 weeks (n = 101) : Meta-analysis results: secondary analysis. Faleck [54], Plevris [43], and Koliani-Pace [49] reported cumulative rates; other studies reported point estimates. The 6-month analysis (a) included data reported from 22 to 30 weeks.…”

Section: Discussionmentioning

confidence: 99%

“…Real-world MH rate ranges were 20.0%-22.2% at 3 months (mean ± SD, 21:3% ± 1:2%; three studies [37][38][39]), 10.1%-46.0% at 6 months (mean ± SD, 30:4% ± 11:8%; ten studies [29,30,[39][40][41][42][43][44][45][46]), and 21.2%-62.5% at 12 months (mean ± SD, 37:8% ± 14:6%; eight studies [28,37,39,43,[47][48][49][50][51]). Cumulative 12-month MH rates were 54%-62.5% in anti-TNF-naïve patients (two studies [28,49]) and 47%-59.7% in anti-TNF-experienced patients [28,49].…”

Section: Statistical Analysesmentioning

confidence: 98%

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Systematic Literature Review and Meta-analysis: Real-World Mucosal Healing in Vedolizumab-Treated Patients with Crohn’s Disease

et al. 2022

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Background. Vedolizumab is a gut-selective monoclonal anti-α4β7-integrin antibody approved for the treatment of adults with moderately to severely active Crohn’s disease (CD). Aim. To conduct a systematic literature review and meta-analysis of published real-world studies examining mucosal healing (MH) rates in patients with CD treated with vedolizumab in routine clinical practice. Methods. MEDLINE-, Cochrane-, and EMBASE-indexed publications from January 2014 to January 2020 and 2018-2019 conference abstracts were searched for real-world studies reporting MH-related outcomes in vedolizumab-treated adults with CD. A meta-analysis was conducted in R to generate pooled estimates of MH. The primary analysis included studies reporting point estimates of MH/endoscopic remission as absence of ulcers/erosions and/or Simple Endoscopic Score for CD (SES-CD) cut − points < 4 , at 6 and 12 months. Results. The systematic literature review included 36 studies, predominantly of antitumour necrosis factor-experienced patients. MH and endoscopic remission were the most frequently reported endpoints. MH rates were 10.1%-46.0% at 6 months (ten studies) and 21.2%-62.5% at 12 months (eight studies). Fifteen studies defining MH as absence of ulcers/erosions and/or SES-CD cut − points < 4 were included for meta-analysis. Pooled MH rates for the primary analysis were 31.8% at 6 months (95% confidence interval (CI): 25.6-38.3; five studies, N = 223 ) and 33.4% at 12 months (95% CI: 25.9-41.4; three studies, N = 151 ). Conclusion. Approximately one-third of vedolizumab-treated patients with CD achieved MH at both 6 and 12 months in real-world clinical settings, despite utilisation in largely biologic-refractory patients. These findings confirm the effectiveness of vedolizumab for achieving MH in patients with CD.

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Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated With Improved Effectiveness and Disease Outcomes

Cited by 13 publications

References 13 publications

Vedolizumab Trough Levels in Children With Anti‐Tumor Necrosis Factor Refractory Inflammatory Bowel Disease

Vedolizumab Trough Levels in Children With Anti‐Tumor Necrosis Factor Refractory Inflammatory Bowel Disease

Comparative safety and effectiveness of vedolizumab to tumour necrosis factor antagonist therapy for Crohn's disease

Systematic Literature Review and Meta-analysis: Real-World Mucosal Healing in Vedolizumab-Treated Patients with Crohn’s Disease

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